Recruiting
Phase 3

Precem-TcT & FTD-TPI

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT07549412

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Precemtabart tocentecan

Bevacizumab

Trifluridine/Tipiracil (FTD-TPI)

Study Details

Brief summary:

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab.

Conditions

Metastatic Colorectal Cancer

Study ID

NCT07549412

Start date

May 6, 2026

Status verified date

Aug, 2026

Completion date

Oct 16, 2029

Anticipated

Primary completion date

Oct 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
  • Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
  • Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations
  • Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  • If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0
  • Participant has a history of additional malignancy within 3 years before randomization
  • Participants with known brain metastases
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
  • Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments
  • Other protocol defined exclusion criteria may apply

Study Design

Enrollment

1020 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy

experimental: Arm 2: Precem-TcT plus Bevacizumab

active comparator: Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab

Interventions

Precemtabart tocentecan

Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.

Bevacizumab

Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.

Trifluridine/Tipiracil (FTD-TPI)

FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.

Primary outcome measure

  • Arm 1, 2 and 3: Overall Survival [ Time Frame: Time from date of randomization to death, assessed approximately up to average of 19 months ]

Central Contacts and Locations

Central contacts

US Medical Information

888-275-7376eMediUSA@emdserono.com

Communication Center

+49 6151 72 5200service@emdgroup.com

Locations

Rocky Mountain Cancer Centers, LLP- Aurora

Recruiting

Lone Tree, Colorado, United States, 80124

Florida Cancer Specialists-Broadway

Recruiting

Fort Myers, Florida, United States, 33901

Florida Cancer Specialists - St. Petersburg Bayfront

Recruiting

St. Petersburg, Florida, United States, 33701-4553

Florida Cancer Specialists East - FCS EAST - West Palm Beach

Recruiting

West Palm Beach, Florida, United States, 33401

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Illinois CancerCare PC

Recruiting

Peoria, Illinois, United States, 61615-7822

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Profound Research LLC at Cancer and Leukemia Center

Recruiting

Sterling Heights, Michigan, United States, 48098

Minnesota Oncology Hematology, P.A.

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Missouri Cancer Associates - 150518964

Recruiting

Columbia, Missouri, United States, 65201

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology, P.A. - Abilene - 300210366

Recruiting

Abilene, Texas, United States, 79606

Texas Oncology-South Austin

Recruiting

Austin, Texas, United States, 78745

Texas Oncology DFW

Recruiting

Bedford, Texas, United States, 75246

Texas Oncology- San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Texas Oncology, P.A. - Tyler

Recruiting

Tyler, Texas, United States, 75702

Virginia Oncology Associates

Recruiting

Newport News, Virginia, United States, 23606

Blue Ridge Cancer Care - 300202915

Recruiting

Roanoke, Virginia, United States, 24014-2419

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • CEACAM5
  • Antibody-drug conjugate
  • Exatecan
  • M9140
  • Precem-TcT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-08-14.